The peak professional body for doctors in Australia — the Australian Medical Association (AMA) — has published its submission for the Therapeutic Goods Administration’s (TGA’s) review into unapproved medicinal cannabis products.
The TGA’s public consultation was launched in August amid growing concerns surrounding access to unapproved medicinal cannabis products available in Australia — particularly those with high levels of the intoxicating cannabinoid tetrahydrocannabinol (THC). The submission deadline was October 7.
The AMA is one of those who submitted a document. The AMA states in a letter that accompanies the submission:
The AMA has always advocated for a strong, evidence-based regulation framework to ensure patient safety, clinical quality, and ethical prescribing. The rapid expansion of medicinal cannabis prescribing — particularly through vertically controlled, direct-to-consumer telehealth models — has exposed significant gaps in the current regulatory framework.”
Among its recommendations are a temporary product ban on high THC products and a prescription volume limit. This, according to the AMA will improve patient safety until the regulations for medicinal cannabis can be reviewed.
The AMA expressed concern in its submission about liquids containing high THC concentration intended for inhalation or devices that allow rapid pulmonary absorption. These, it says, pose disproportionate risk compared with orally titrated oils or products.
The AMAs are packed with information. 11-page submissionThe organisation also says that:
- The current labeling requirements for non-approved medical cannabis products are inadequate and make recommendations.
- The Australian Register of Therapeutics Goods (ARTG), within a fixed period, should register all products that are used in excess of the exception access.
- The packaging should include a calibrated dose aid and be resistant to children.
- Compound products that are not regulated and have unclear ratios of cannabinoids in them should be banned.
- Gradually increasing controls are needed, i.e. more strict frameworks for higher levels of THC.
- The AMA opposes restricting access of pregnant women and breastfeeding mothers to THC-containing products.
- If you have a family history of serious mental illnesses, are addicted to drugs or alcohol, suffer from significant cardiovascular problems, work in a safety-critical profession, etc., then it is recommended that you screen patients and reduce their risk.
The AMA doesn’t support a blanket prohibition of access to non-approved medical cannabis products, as they believe that the Special Access Schemes (SAS) or Authorised Prescribers (AP) must be available in exceptional cases.
You can also find out more about the following: TGA says It will review submissions in order to inform future options of changes to the regulatory framework. Further consultations with stakeholders for proposed reforms will also be conducted.